Please Note: HuFriedyGroup was divested from STERIS on May 31, 2024.  We are currently in a transition period, working to re-establish our own HuFriedyGroup Careers site and job posting pages. Until the new site and pages are ready, career opportunities that are specific to jobs at HuFriedyGroup will continue to be published on the STERIS site. Our Talent Acquisition team will be working diligently to ensure a positive and seamless experience for our candidates.

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance  and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Position Summary

The Senior Document & Data Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

What We Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing:

 

Competitive salaries Healthcare benefits  Tuition assistance Paid-time off Paid holidays Matching 401(k) Annual merit increases Annual bonus

 

Join us and help write our next chapter.

What You Will Do Complete document control transactions. Manage Customer complaint investigations and complete complaint documentation. Facilitate CAPA and NCR investigations and may coordinate investigation documentation. Review DHR’s and support batch record release. Manage record retention practices within the site. Manage site calibration activities and recordkeeping. Support site inspection activities and recordkeeping. Coordinate internal and external audits. Support supplier quality and Customer assessment activities. Track and trend site Quality data. Support targeted Lean activities. Complete other duties as assigned. Education Degree Associate's Degree What Will Help You Be Successful Associate's degree required. Two (2) years experience in Quality in a regulated industry (i.e. FDA/ISO 13485). PC familiarity with MS Office applications including Word, Excel and MS Teams.

 

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Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-time Employees are also eligible for short-term disability.  Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid holidays.  Part-time Employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid holidays based on their standard hourly work week. Full-time Employees are eligible for four weeks of paid parental leave.  Part-time Employees also receive paid parental leave, pro-rated based on their standard hourly work week.

HuFriedyGroup is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state, or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.